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Taking people in United StatesPhase 2

Online Sleep Therapy Tested for Insomnia in Older Adults With Memory Problems

Tests an internet-based insomnia program in older adults with mild cognitive impairment.

Key facts

Who runs it
University of Virginia
Where
Charlottesville, United StatesSee the site
Trial code
Registry title
Sleep Healthy Using the Internet Mitigating Insomnia to Address Neurocognitive Difficulties (SHUTi MIND)
Status
Recruiting
Phase
Phase 2
People taking part
144 people, planned
Started
27 Feb 2023
Expected to end
Jan 2028
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • SHUTi OASIS
  • Patient Education
Record updated
8 May 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 65 or older who have trouble sleeping and some cognitive impairment. It tests an internet-based sleep program against patient education.

Age
65 years or older
Sex
Men and women
Disease stage
Insomnia (trouble falling asleep or staying asleep) that causes distress or problems in daily life over the past three months, together with cognitive impairment found by the study assessment.
Earlier treatment
Cannot be in current psychological treatment for insomnia. Medication must be stable unless it is known to cause insomnia.

Main reasons for not taking part

  • Another untreated sleep disorder, such as obstructive sleep apnea
  • Parkinson's or Huntington's disease
  • Psychotic or bipolar disorder
  • Severe depression or moderate to high risk of suicide
  • Alcohol or drug abuse within the past year

The registry criteria, word for word

Show all 25 criteriaShow less

Who can take part

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Male or female, aged ≥ 65 years of age
  • Able to speak and read English, and is a US resident
  • Have access to any Internet-enabled device (computer, tablet, smartphone) and willing to be emailed about the study
  • Sleep-onset insomnia and/or sleep maintenance insomnia symptoms
  • The sleep disturbance (or associated daytime fatigue) causes significant distress or impairment in social, occupational, or other areas of functioning over the past three months
  • Cognitive impairment through study assessment
  • Stable medication regimen unless medication is known to cause insomnia

Who cannot take part

  • Currently undergoing chemotherapy
  • Chronic pain treated with opioids
  • Use of stimulating medications after 5pm or taken for less than 3 months
  • Alcohol or drug abuse within the past year
  • Initiation of psychological or psychiatric treatment within the past three months
  • Current diagnosis of Huntington's or Parkinson's disease
  • Not recovered from a brain tumor, injury, or infection
  • Epilepsy without stable treatment for at least 3 months
  • Psychotic or bipolar disorder
  • Other untreated sleep disorders (e.g., obstructive sleep apnea)
  • Current psychological treatment for insomnia
  • Current treatment for hyperthyroidism
  • Presence of asthma or respiratory concerns with night treatment
  • Irregular sleep schedule
  • Moderate to high risk of suicide
  • Study screen for severe depression

Where in United States

  • University of VirginiaCharlottesville, United StatesContact: Meghan Mattos, PhDTaking people

About the trial

What the trial wants to find out

This randomized controlled trial will evaluate the impact of an Internet-delivered cognitive behavioral therapy for insomnia (CBT-I) intervention on sleep and the extent to which it contributes to cognitive health in individuals with mild cognitive impairment. Participants with insomnia who meet the study criteria for mild cognitive impairment will be recruited to determine the effects of the CBT-I intervention compared to a patient education condition on sleep and cognition. Internet-based recruitment methods will be used, and outcomes include sleep variables, daytime variables, and cognitive status.

The 2 groups in the trial

  • SHUTi OASISTreatment being tested

    Participants will be assigned to the SHUTi (Sleep Healthy Using the Internet) for Older Adult Sufferers of Insomnia and Sleeplessness (OASIS) online intervention optimized for older adults. CBTi will be delivered online and metered out over time with each new core becoming available one week after the completion of the previous core. The intervention period is 9 weeks. They will spend 1-2 hours during the intervention period completing daily sleep diaries as well as interactive core content covering topics of sleep behaviors, sleep thoughts, sleep education, and relapse prevention targeting issues specific to older adults. As users progress through the intervention, they will receive automated, tailored instructions on how to improve their sleep.

  • Patient Education WebsitePlacebo, for comparison

    Participants will be assigned to a relevant patient education website. It will include information about insomnia symptoms, diagnosis, prognosis, and information about CBT strategies for the older adult. Unlike SHUTi, the content will not be tailored and will be presented all at once.

    Treatment: Patient Education

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Internet-based Insomnia Intervention to Prevent Cognitive Decline in Older Adults With Mild Cognitive Impairment (SHUTi MIND)
Plain-language title
Online Sleep Therapy Tested for Insomnia in Older Adults With Memory ProblemsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
8 May 2024